How to Export Food and Dietary Supplements to the USA: Understanding FDA Facility Registration and the Role of a US Agent

The Importance of Facility Registration and a US Agent

Exporting food and dietary supplements to the United States is a significant opportunity for international businesses, given the high demand for quality food and health products. However, strict US Food and Drug Administration (FDA) regulations must be followed to ensure compliance, product safety, and smooth market entry.

A key requirement for foreign manufacturers, processors, packers, and holders of food products is FDA facility registration under the Food Safety Modernization Act (FSMA). Additionally, every foreign facility must appoint a US Agent who acts as a representative for FDA communications. These steps are fundamental to ensuring regulatory compliance and avoiding delays or refusals at US ports.

FDA Facility Registration: A Mandatory Step

The FDA facility registration process applies to any foreign entity that manufactures, processes, packs, or holds food and dietary supplements intended for the US market. This registration is essential because it allows the FDA to monitor imported food products and ensures compliance with US food safety regulations.

Key Aspects of FDA Facility Registration:

• Required for all food and dietary supplement facilities outside the US exporting to the American market.
• Obtain a DUNS number (UFI) to identify the physical facility address.
• Biennial renewal, meaning facilities must renew their registration every two years.
• Updated contact details and compliance verification to ensure the FDA can reach the facility if needed.
• Failure to register or renew can result in shipment delays, refusal at the border, or legal action by the FDA.

The Role of a US Agent in FDA Compliance

Every foreign food and dietary supplement facility is required to appoint a US Agent as part of the FDA registration process. The US Agent serves as the official point of contact between the FDA and the foreign facility, ensuring regulatory compliance and effective communication.

Responsibilities of a US Agent:

• Acts as a liaison between the FDA and the foreign facility.
• Receives and responds to official FDA communications, including inspection notices and compliance inquiries.
• Assists with Prior Notice filings, ensuring smooth importation of food products.
• Supports in handling regulatory matters, including facility inspections and import alerts.

Why FDA Facility Registration and a US Agent Are Essential for Exporters

Compliance with FDA facility registration and the appointment of a US Agent is not just a regulatory requirement but a crucial step in avoiding shipment delays and ensuring smooth market access. The FDA actively monitors compliance, and non-compliance can result in:

• Refusal of entry for products at US ports.
• Administrative delays affecting supply chain efficiency.
• Legal consequences and penalties.

How Cosmereg Can Assist

At Cosmereg, we specialize in regulatory compliance and provide comprehensive support to businesses looking to export food and dietary supplements to the USA. Our services include:

• FDA Facility Registration: Ensuring your facility is properly registered and remains compliant with renewal deadlines.
• Acting as Your US Agent: Serving as your official point of contact with the FDA to facilitate smooth communication and compliance.
• Regulatory Advisory Services: Guiding you through FSMA requirements, cGMPs, and FSVP compliance.
• Importation Support: Assisting with Prior Notice filings and responding to FDA inquiries to prevent importation delays.
• Ongoing Compliance Monitoring: Keeping your business aligned with evolving FDA regulations.

With extensive experience in FDA regulatory compliance, Cosmereg ensures that your products meet all necessary requirements for successful export and market entry into the United States.

For businesses looking to export food and dietary supplements to the USA, proper FDA facility registration and the appointment of a US Agent are non-negotiable regulatory steps. These measures ensure compliance, prevent costly delays, and facilitate seamless importation into the US market.

Partnering with Cosmereg simplifies the compliance process, allowing businesses to focus on expanding their reach while we handle the regulatory complexities. Contact us today to ensure your FDA registration and US Agent representation are fully in place for a successful market entry.

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